Neurobehavioural and Cognitive Changes in Cancer Cachexia (CANCOG)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Cambridge
About this trial
The goal of this observational study is to to look for changes within the brain, and changes in body-to-brain signals in people with cancer and people who do not have cancer. The main questions it aims to answer are:
1. Are there differences in areas of the brain known to be related to appetite control, food reward and motivation, between participants with cancer related weight loss and healthy volunteers 2. Do responses to questionnaires and computer based tasks suggest participants with cancer related weight loss have reduced appetite and reduced motivation to eat compared to healthy volunteers, and if so, do questionnaires suggest that this is associated with any other symptoms?
Researchers will compare the structure and blood flow in relevant areas of the brain using MRI images between participants with cancer related weight loss and healthy volunteers. Participants will complete questionnaires and computer based tasks to allow researchers to assess areas of the brain which become more active in response to different stimuli. Some computer based tasks will be performed during the MRI scan. This is called functional MRI.
A further objective is to obtain an archive of blood samples which will be stored securely for future analysis if relevant hormones or analytes are identified that may be relevant to metabolism or body composition
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Written informed consent
Aged 18 years or over
Willing and able to comply with study procedures and visits
Histological or cytological diagnosis of cancer or confirmed non-intracranial malignancy on imaging.
Disqualifiers
Non-fluent English speaker
Active infection, as determined by the investigator based on clinical symptoms and / or fever and / or requirement for antibiotics
Women, who are pregnant, plan to become pregnant or are lactating.
MRI contraindication
Trial population
A maximum of 50 participants will be recruited to this study over a period of 4 years. This will include approximately 30 participants with cancer, and 20 healthy volunteers. Participants with cancer will be recruited from oncology outpatient clinics or multi-disciplinary team meetings including palliative care MDT meetings at Addenbrooke's Hospital, Cambridge. Healthy volunteers will be recruited by advertising on site, study recruitment notice boards or through a contact of the participant with cancer. Participants in each group will be matched for age and sex
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
MRI/ Functional MRI
Procedure/SurgeryParticipants will undergo an MRI scan lasting approximately 1 hour to examine the structure and function of the brain. During the scan, they will also be asked to perform computer based tasks. This is called functional MRI.
Self-reported questionnaires
BehavioralParticipants will complete questionnaires covering subjective measures relating to food attitudes and intake, and report-based measures of relevant psychopathology including depression and anxiety. These will be derived from standardised scales already used clinically, including the setting of eating disorders and normative studies of the neuroscience of appetite.
Computer based tasks
BehavioralParticipants will complete computer based tasks which are focused specifically on aspects of appetite-related and reward behaviours. Typically, such behaviours are characterised under the following sub-headings: i) Motivation (the amount of effort, cognitive or physical, that a person is prepared to expend in order to gain access to food), ii) Valuation (the relative rating of foods in comparison to each other and to non-food items), and iii) Hedonic response (the subjective pleasure experienced in consumption) to food intake
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Participants with cancer and cancer associated weight loss/ loss of appetite3 interventions
Group B: Healthy volunteers3 interventions
Trial outcomes
Primary outcomes
1
To characterise structural and functional neuroanatomy as well as neurometabolism through MRI brain imaging in participants with cancer related weight loss and healthy volunteers.
Eligible participants will undergo an MRI scan during a 1-hour scanning session at Wolfson Brain Imaging Centre.
Time frame
1 hourSecondary outcomes
1
To determine if there is a difference in food motivation and reward -based behaviour using functional MRI.
Participants will be asked to perform one computer based task during their MRI scan, which is called functional MRI. Imaging analysis of the results of this task will indicate differences in MRI responses in areas of the brain related to food reward and food motivation, between people with cancer and weight loss and healthy volunteers.
Time frame
1 hour2
Participants will be asked to perform two computer based tasks after the MRI scan, which have been validated to assess food reward and motivation.
Participants will be asked to perform two computer based tasks using a laptop. The generated results of these tasks will indicate participants' level of food reward and food motivation and will allow for comparison between people with cancer and weight loss, and healthy volunteers.
Time frame
2 hours3
To compare responses to questionnaire-based measures of food attitudes, food intake and relevant psychopathology across patients with cancer related weight loss and healthy volunteers.
The following questionnaires cover food attitudes and intake, and measures of psychopathology including depression and anxiety. These will be derived from standardised scales, used the setting of eating disorders and neuroscience of appetite studies. Questionnaire scores will be compared between people with cancer and weight loss and healthy volunteers. Godin Leisure Time Exercise Questionnaire Functional Assessment of Chronic Illness Therapy- Fatigue Functional Assessment of Anorexia/Cachexia Therapy Activities of daily living questionnaire Instrumental activities of daily living scale Scored Patient Generated Subjective Global Assessment Edmonton Symptom Assessment Brief Pain Inventory Patient Health Questionnaire- 9 General Anxiety disorder Hospital Anxiety and Depression Scale Body Perception Questionnaire Snaith Hamilton Pleasure Scale The three factor eating questionnaire DSM-5 Self rated Level 1 Cross-cutting symptom measure
Time frame
1 hour4
To secure an archive of blood samples for potential future analysis as other targets may become available with research progression locally or within the wider CANCAN consortium
A 10-20ml blood sample will be collected from all participants
Time frame
5 minutesSponsors and contacts
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Source ClinicalTrials.gov